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How Does a Medical Device Wind Up in Your Body?

A shocking documentary called The Bleeding Edge was released in July of 2018. This “searing” exposé looked at select cases of patients who were seriously injured by medical devices, and their attempts to find answers for why this had been allowed to happen to them. Recently, The Danger Within Us – a book by a former physician turned investigative journalist – covered the same thing: an estimated $156 billion medical device industry gone wild.

Let’s begin with the basics. What is a medical device?

A medical device is any article, instrument, apparatus, or machine that prevents, diagnoses, or treats an illness. Pacemakers, defibrillators, syringes, ventilators, hernia mesh, catheters, stents, breast implants, MRI machines, IVC filters, hip implants, dialysis machines, and even surgical gloves are just a few examples of such devices. Medical devices are also used to detect, measure, restore, correct, or modify the structure or function of the body for a health purpose. (SelectUSA.gov)

It may surprise you to learn that many medical devices on the market today underwent little to no clinical testing before being used on or implanted in a patient. It is no wonder they can end up causing unforeseen side effects, seriously injuring their hosts.

The U.S. Food and Drug Administration is responsible for regulating the device industry, but many critics believe that the federal agency has loopholes in place that allow untested products to make it into doctors’ hands – and people’s bodies.

A Short History of Medical Devices

The 1950s and ‘60s saw a boom in technology in the Western world, including medical technology. Many devices in the form they are used today were originated at this time, including metal-on-metal hip implants (1953) and surgical (hernia) mesh (1955). Nominally, the U.S. Food and Drug Administration (FDA) was in charge of overseeing medical devices in America. However, it wasn’t until the Medical Device Amendment of 1976 to the Federal Food, Drug, and Cosmetic Act that the FDA was allowed to impose production, distribution, and sales rules on device manufacturers.

Every device already on the market prior to 1976 was “grandfathered in,” requiring none of the safety testing that devices would have to undergo moving forward.

The Safe Medical Devices Act of 1990 further expanded the FDA’s authority to regulate medical devices. Since 1991, hospitals have been required to report serious injury, death, or other “adverse experiences” related to medical devices to both the device manufacturer and the FDA. “Adverse experiences” include concussions, fractures, burns, paralysis, and loss of sight, hearing, or smell.

How Are Medical Devices Approved Today?

When a manufacturer comes up with a new medical device, it must be approved by the FDA before it can be put on the market and sold to the public. Here are the major steps:

The device must be classified. There are three categories of device: class I (low to moderate risk to a patient), class II (moderate to high risk), and class III (high risk). An implantable device like a pacemaker or hip implant, which “presents a potential, unreasonable risk of illness or injury” to a patient, would fall into class III. The manufacturer of the new device is allowed to choose the device classification, though the FDA can reject the choice if the FDA feels the device is higher risk.

The device must go through premarket submission with the FDA. Depending on the classification, the new device will generally have to apply for approval through the 510(k) Premarket Notification process, the De Novo process, or the Premarket Approval Application.

Premarket Approval (PMA): The most stringent set of controls for a device, premarket approval is a “scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the class III device.” PMA requires valid clinical tests performed on the use of the device; non-clinical laboratory tests covering microbiology, toxicology, immunology, biocompatibility, stress, wear, shelf life, etc.; and sound scientific reasoning and statistical analyses backing up the data. Ideally, all class III devices on the market will have gone through PMA, but that is not the case.

510(k) Premarket Notification (PMN): Usually reserved for class I or class II devices, premarket notification is for devices that are “substantially equivalent” to another predicate device already on the market, even if the predicate device was pulled for defects. There is no clinical testing requirement. One example of a device that made it to the market through PMN is the DePuy Pinnacle metal-on-metal hip implant system, which had to be discontinued due to high rates of failure (and surgical revision) in patients. It should also be noted that the FDA states, “The burden is on the 510(k) holder to decide whether or not a modification could significantly affect safety or effectiveness of the device.” In essence, the device manufacturer gets to tell the FDA what is safe…not the other way around. (It should also be noted that the Institute of Medicine recommended eliminating the PMN approval process in 2011.)

Evaluation of Automatic Class III Designation (De Novo): When there is no predicate device, or a new device receives a high-level not-substantially-equivalent (NSE) determination from the FDA, manufacturers can petition to have the device evaluated and placed into class I or class II and be subjected to the 510(k) pathway instead of PMA.

Once approved by the FDA, a device can be marketed to the public and offered for sale. Certain devices are granted conditional approval and postmarket studies must still be conducted…as those devices are used on live patients, who have no idea that they are still under review.

Adverse events must be reported. Pursuant to the Safe Medical Devices Act, any adverse events must be reported to the FDA and device manufacturer by the healthcare provider overseeing the use of the device. But that’s not always what happens.

Physicians are reluctant to report adverse medical device events (AMDEs), a British Medical Journal study shows. They perceive such reporting as “unnecessary, not possible or futile” based on institutional factors and a lack of device industry responsiveness. Consumers are able to report their own adverse events in the FDA’s MAUDE database, but the system is too confusing for the average patient. According to an Institute of Medicine publication, “Voluntary reports from healthcare professionals and consumers also account for a small percentage of reports (about 3 percent each year).”

In addition, some physicians have good reason to play up the benefits of medical devices and downplay the side effects: this ProPublica project tracks the amount of money that has been paid by device manufacturers to doctors. Kickbacks and promotion lead to more doctors recommending medical device surgery for patients who don’t need it – and quite possibly, devices that can be deadly.

How a Medical Device Can Go Wrong

A baby boy is delivered using a vacuum extractor. He suffers bleeding under his scalp at birth, and is rushed to the hospital’s neonatal intensive care unit, but it is too late. Reviewing the case, experts find that the hemorrhage was caused by a defective gauge in the vacuum extractor, which read the level of suction in the “safe” zone even though it was dangerous, and caused the fatal hemorrhage.

A 9-year-old boy has been hospitalized for a severe asthma attack. He requires oxygen therapy and aerosolized treatments, as well as antibiotics. A nurse attaches the tubing for his daily intravenous antibiotic dose, but the end fitting for the tube is identical to the boy’s oxygen tube – and the nurse, distracted by something the boy says, connects the wrong one, sending air into his intravenous line – a fatal embolism. Though the proximate cause of the child’s death was the nurse’s error, the tubing design contributed to this mistake because it allowed the incorrect connection, and lacked clear labeling.

Both of these examples are hypothetical “vignettes” from Safe Medical Devices for Children, a committee review on postmarket surveillance of pediatric medical devices published by the Institute of Medicine. They highlight a larger problem: new devices are pouring out faster than we can keep track of them – whether they harm patients or not. An estimated 6.7 million people have medical devices implanted in their bodies every year, according to Jeanne Lenzer, author of The Danger Within Us.

As technology expands, medical device manufacturers are constantly changing their devices – both the design as well as the manufacturing process. Small changes can become big problems, as seen with the DePuy ASR XL hip implant system. A plastic liner was removed and a larger “socket” created to increase the stability of the hip – but this led to grinding between the two metal surfaces, releasing metallic particles into patients’ blood and tissue, causing tissue death and heavy metal poisoning.

What Can You Do After a Medical Device Injures You?

It’s a brave new world out there, in our hospitals as well as our homes. If you were injured by an adverse reaction caused by a medical device, it may be difficult to recover just compensation. The bureaucratic red tape surrounding device regulation is no accident, and knowing the science and data behind why a device failed is hugely complex, often at a molecular level.

However, an experienced medical product liability attorney at Leventhal & Puga, P.C., would know what to do. Our team of nationally acclaimed trial lawyers has handled litigation involving defective devices across the United States, with successful results for our clients.

If you call us with your situation, we’ll examine your records and let you know if you have a viable case against a device manufacturer or hospital for compensation. Please contact our Denver office online or call (877) 433-3906 for a confidential, no-cost consultation.